The concept of disposable containers for the collection of bodily fluid specimens such as urine specimens is well known. The most common form of such a container is a plastic or paper cup. Most of such cup-type disposable containers include some sort of closure lid. The disadvantages to cup-type containers for the collection of specimens are at least three-fold. First, the cups are rather small in volume with relatively small openings, and patients, especially women, sometimes find it difficult to deposit a bodily fluid specimen such as urine in the cup without spillage or overflow. Second, once the fluid is deposited in the container, the fluid is sometimes spilled in the process of being delivered to a nurse or technician for testing Third, there is no easy way to deposit a test strip in the fluid so that it can be visually inspected in the fluid. Placing a test strip in the fluid requires that the lid of the container be removed, and this requirement enhances the likelihood of the specimen being spilled and coming into contact with the nurse or technician.
U.S. Pat. Nos. 3,797,734 and 4,990,145 show a disposable bag of the type with which the present invention is intended to be used. Specifically, the '734 patent shows a bag having a tubular funnel sealingly engaging a plastic bag. The bag is sealably attached to the outer surface of the tubular member. The lower end of the tubular member includes a funnel means comprised of a flattenable plastic tube which allows entry of the fluid through the tubular member into the bag, but which prevents fluid from escaping upward and reentering the tubular member. The '145 patent provides an improvement to the embodiment disclosed in the '734 patent by means of a protective outer sleeve or shroud for protecting the user's skin against fluid contact. As noted in the '145 patent, products made in accordance with both patents have been sold in substantial numbers.
It is imperative that nurses and other medical personnel avoid contact with the bodily fluids of their patients. Hepatitis B virus, HIV (human immunodeficiency virus) and other diseases may be transmitted as a result of contact with bodily fluids. Further, the Occupational Safety and Health Administration (OSHA) has issued regulations covering medical employees that medical practices must comply with (see 29 C.F.R. .sctn. 1910.1030 et seq.).
Thus, there is a need for a disposable specimen container that is easy to use and protects both the patient and medical technician against coming in contact with the bodily fluids. Second, there is a need for a disposable specimen container that may be transported or handed from the patient to a technician without the risk of spillage, either on the patient or on the technician. Third, there is a need for a disposable specimen container that facilitates the insertion of a test strip into the fluid and further facilitates the viewing of the test strip while it is in the fluid without requiring the technician to reach down into the container to retrieve the test strip for inspection.
As discussed below, the present invention satisfies all three of the aforenoted criteria.